NCT00068614

HER-2 Protein Vaccine in Treating Women With Breast Cancer

A Phase I Trial Evaluating The Safety Of Intramuscular Injections Of HER-2 Protein AUTOVAC (PX104.1.6) In Patients With Breast Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of HER-2 protein vaccine in treating women who have breast cancer.

Detailed description

OBJECTIVES: Primary * Determine the safety of HER-2 protein AutoVac™ in women with breast cancer. Secondary * Determine the ability of this drug to bypass the tolerance to the HER-2 self-protein by raising HER-2 antibodies in these patients. * Determine the kinetics of the immune response to HER-2/neu in patients treated with this drug. OUTLINE: This is an open-label, multicenter study. Patients receive HER-2 protein AutoVac™ intramuscularly at weeks 0, 2, 6, and 10 in the absence of unacceptable toxicity. Patients are followed for up to 6 weeks. PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study within 3 months.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
BIOLOGICAL	HER-2/neu peptide vaccine

Timeline

• Start date: 2003-07-01
• Primary completion: 2005-10-01
• First posted: 2003-09-11
• Last updated: 2014-02-05

Locations

1 site across 1 country: United States